ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of April 5, 2013 No. 173

About approval of the Technical regulation "About Safety of Products of Medical and Veterinary Appointment for Laboratory Diagnostics in Artificial Conditions (in Vitro)"

According to the Law of the Kyrgyz Republic "About bases of technical regulation in the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the enclosed Technical regulation "About Safety of Products of Medical and Veterinary Appointment for Laboratory Diagnostics in Artificial Conditions (in Vitro)".

2. This resolution becomes effective after six months from the date of official publication. This resolution is effective before entry into force in the territory of the Kyrgyz Republic of the corresponding technical regulation of the Customs union.

Approved by the Order of the Government of the Kyrgyz Republic of April 5, 2013, No. 173

Technical regulation "About Safety of Products of Medical and Veterinary Appointment for Laboratory Diagnostics in Artificial Conditions (in Vitro)"

Chapter 1. General provisions

1. This Technical regulation of the Kyrgyz Republic "About safety of products of medical and veterinary appointment for laboratory diagnostics in artificial conditions (in vitro)" (further - the Technical regulation) establishes:

1) essential requirements to production processes, transportations, storages, utilizations and destructions of products of medical and veterinary appointment for laboratory diagnostics in artificial conditions (in vitro);

2) classification of products of medical and veterinary appointment for laboratory diagnostics in artificial conditions (in vitro) for the purposes of application of this Technical regulation;

3) forms of assessment of conformity of products of medical and veterinary appointment for laboratory diagnostics in artificial conditions (in vitro) to requirements of this Technical regulation.

2. Products types falling under action of this Technical regulation and their codes on the Commodity Nomenclature of Foreign Economic Activity qualifier are specified in appendix 1 to this Technical regulation.

3. This Technical regulation does not extend on:

1) medicines;

2) the human blood or components of blood, plasma used as remedies;

3) the medicines prepared from blood or plasma;

4) the human fabrics or cages intended for transplantation;

5) fabrics or the cages of animal origin intended for transplantation;

6) the products of medical and veterinary appointment which are not intended only for diagnostics in artificial conditions (in vitro).

4. Requirements to safety of devices by means of which interpretation of results in case of application of products of medical and veterinary appointment is made for laboratory diagnostics in artificial conditions (in vitro) are carried out according to the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Products of Medical Appointment" of February 1, 2012 No. 74.

5. Subjects to regulation of this Technical regulation are new products of medical and veterinary appointment for laboratory diagnostics in artificial conditions (in vitro), irrespective of the country and the place of origin, and production processes, transportations, storages, utilizations and destructions of these products.

6. For the purposes of this Technical regulation the following basic concepts are used:

in vitro - the medical tests which are carried out in controlled environment out of live organism;

antigen - substance which reversibly and not covalently contacts the specific centers of antibodies;

antibodies - the proteins produced by lymphocytes In which use for binding, detection or determination of antigen;

biological agents - microorganisms (bacteria, viruses, mushrooms, protozoa, prions), including the microorganisms received by methods of genetic engineering, components of microorganisms, products of their life activity and disintegration;

outside package - any form of packaging in which the inside package (inside packages) is placed;

inside package - any form of packaging which is directly contacting to product of medical and veterinary appointment for diagnostics in artificial conditions of in vitro;

genome - set of all genes of organism;

detection - identification, detection something (for example, alcohol in blood, etc.);

diagnostics of in vitro - system of the laboratory diagnostic procedures which are carried out with biological samples of human body or animals;

products of medical and veterinary appointment for laboratory diagnostics in artificial conditions (in vitro) (further - products for diagnostics) - sets for diagnostics, reagents, reactants, environments, test systems, strips the indicator, calibrating and control materials and other diagnostic aids intended for research in artificial conditions (in vitro) of the samples taken from body of the person or animal for the purpose of receipt of information necessary for assessment and maintenance of certain functions of the person or animal (for example, for diagnosis of disease and its prevention, control of course of disease during certain treatment, etc.);

interference - reduction of amount and quality degradation of the reproduced material, or increase in time of the solution of task (in case of interference of the selection);

set components - reagents (reactants) and components (tablets, strips, test tubes, etc.);

variation coefficient - the indicator of reproducibility of results of determination calculated as the relation of value of average quadratic deviation to arithmetic average to value;

linearity - variation of value of concentration of the determined substance (or activities of enzyme) from theoretical in the range of working concentration;

set - the set of specially picked up reagents (reactants), components and instructions for carrying out the analysis intended for determination in artificial conditions (in vitro) of one specific substance (or activities of enzymes), and also for detection of the site of genome;

products of medical appointment, unsuitable to medical application, - the products of medical appointment posing hazard to life and health of the person;

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